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Comparison of Quantitative MRI Perfusion Methods With Quantitative PET Perfusion Imaging

Comparison of New MRI Methods for Quantitative Assessment of Myocardial Perfusion With Quantitative PET Perfusion Imaging

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02608944
Enrollment
0
Registered
2015-11-20
Start date
2012-09-30
Completion date
2019-06-12
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRI Scans

Brief summary

This work seeks to develop, evaluate and use new MRI methods for non-invasive quantitative assessment of myocardial perfusion and perfusion reserve (MPR), and to compare with quantitative PET imaging.

Detailed description

This project aims to determine the validity of quantitative MRI perfusion methods by comparison with quantitative PET imaging. First pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson. After custom reconstruction and post-processing the data will be fit to a compartment model and quantitative perfusion and MPR values obtained. On another day, the subjects will have quantitative PET imaging with O-15 labeled radioactive water. This will be done at rest and hyperemia caused by either adenosine or regadenoson. A low dose CT scan will be acquired to perform attenuation correction of the PET images. The images will be reconstructed and processed as reported in the literature to provide reference standard perfusion and MPR values. These values will be compared with those obtained by MRI.

Interventions

DEVICEMRI

Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson

DRUGAdenosine

Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion

DRUGRegadenoson

Regadenoson: 0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.

O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging

DEVICEPET Imaging

Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day.

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Inclusion Criteria: * All participants will be over the age of 18 and able to provide consent * Both healthy and subjects with cardiac disease (including atrial fibrillation but not required) will be recruited. *

Exclusion criteria

* Critically ill patients, patients on ventilators, patients with unstable angina or with hypotension, asthmatics, and other patients whose medical care or safety may be at risk from undergoing an MRI examination will be excluded. * Patients with claustrophobia will also be excluded from the study if this cannot be controlled with standard methods (valium or benadryl). * Patients with contraindication to MRI (pacemaker, metal implants, or certain types of heart valves), * pregnant patients, minors, mentally disabled patients and prisoners will be excluded from this study. (All criteria apply to patients and normal volunteers). * Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidney function (GFR\<30) excluded from the study due to the (very small) risk associated with gadolinium contrast agents. This threshold may be modified, depending on practices determined by the Radiology Department and the IRB. * Patients with a known allergy or contraindication to Adenosine and/or Regadenoson will be excluded from stress (hyperemia) cohorts. * All participants that will receive a stress agent will refrain from consuming caffeine for at least 12 hours prior to each study

Design outcomes

Primary

MeasureTime frameDescription
Myocardial perfusion values from MRIThe scan will take ~1-2 hours. The MRI will be done within 2 months of the PET scan.Myocardial perfusion in segments and coronary territories will be computed in ml/min/g from the dynamic MRI data. The perfusion values will be compared to PET data to determine how similar the values are.
Myocardial perfusion values from PETThe scan will take ~1-2 hours. The PET scan will be done within 2 months of the MRI.Myocardial perfusion in segments and coronary territories will be computed in ml/min/g from the dynamic PET data. The perfusion values will be compared to MRI data to determine how similar the values are.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026